Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00
Study Details
Study Description
Brief Summary
The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multifocal IOL AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation). |
Device: AcrySof IQ PanOptix Multifocal IOL
AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
Other Names:
|
| Active Comparator: Monofocal IOL AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation). |
Device: AcrySof Monofocal IOL
AcrySof Monofocal IOL Model SN60AT for single vision
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) [Month 6 (Day 120-180), post second eye implantation]
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
- Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) [Month 6 (Day 120-180), post second eye implantation]
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
- Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye [Up to Month 6 (Day 120-180), post second eye implantation]
The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.
- Mean Photopic Without Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]
Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
- Mean Photopic With Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
- Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
- Mean Mesopic With Glare Binocular Distance Contrast Sensitivity [Month 6 (Day 120-180), post second eye implantation]
Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Secondary Outcome Measures
- Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) [Month 6 (Day 120-180), post second eye implantation]
VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
- Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire [Month 6 (Day 120-180), post second eye implantation]
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.
- Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) [Month 6 (Day 120-180), post second eye implantation]
QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
- Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID [Month 6 (Day 120-180), post second eye implantation]
Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
-
Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
-
Clear intraocular media other than cataract in both eyes.
-
Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.
Exclusion Criteria:
-
Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
-
Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
-
Glaucoma (uncontrolled or controlled with medication)
-
Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
-
Pregnant or lactating
-
Expected to require a second surgical intervention or retinal laser treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigative Site | Fresno | California | United States | 93720 |
| 2 | Alcon Investigative Site | Mount Dora | Florida | United States | 32757 |
| 3 | Alcon Investigative Site | Panama City | Florida | United States | 32405 |
| 4 | Alcon Investigative Site | Poughkeepsie | New York | United States | 12603 |
| 5 | Alcon Investigative Site | Mount Pleasant | South Carolina | United States | 29464 |
| 6 | Alcon Investigative Site | Sioux Falls | South Dakota | United States | 57108 |
| 7 | Alcon Investigative Site | Nashville | Tennessee | United States | 37205 |
| 8 | Alcon Investigative Site | Houston | Texas | United States | 77027 |
| 9 | Alcon Investigative Site | Hurst | Texas | United States | 76054 |
| 10 | Alcon Investigative Site | Nacogdoches | Texas | United States | 75965 |
| 11 | Alcon Investigative Site | Salt Lake City | Utah | United States | 84107 |
| 12 | Alcon Investigative Site | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon Research, Alcon Research
Study Documents (Full-Text)
More Information
Publications
None provided.- ILH297-C001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 12 investigative sites located in the United States. |
|---|---|
| Pre-assignment Detail | Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243). |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Period Title: Overall Study | ||
| STARTED | 129 | 114 |
| COMPLETED | 127 | 114 |
| NOT COMPLETED | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | TFNT00 | SN60AT | Total |
|---|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | Total of all reporting groups |
| Overall Participants | 129 | 114 | 243 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.8
(7.31)
|
69.0
(6.46)
|
67.3
(7.09)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
85
65.9%
|
79
69.3%
|
164
67.5%
|
| Male |
44
34.1%
|
35
30.7%
|
79
32.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
113
87.6%
|
96
84.2%
|
209
86%
|
| Black or African American |
8
6.2%
|
11
9.6%
|
19
7.8%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
7
5.4%
|
1
0.9%
|
8
3.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
2
1.8%
|
2
0.8%
|
| Other |
1
0.8%
|
4
3.5%
|
5
2.1%
|
Outcome Measures
| Title | Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) |
|---|---|
| Description | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set with data available at the visit |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 113 |
| Least Squares Mean (Standard Error) [logMAR] |
-0.014
(0.0083)
|
-0.039
(0.0087)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TFNT00, SN60AT |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.024 | |
| Confidence Interval |
(1-Sided) 95% to 0.041 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0103 |
|
| Estimation Comments | ||
| Title | Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) |
|---|---|
| Description | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set with data at visit |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 113 |
| Measure Eyes | 127 | 113 |
| Least Squares Mean (Standard Error) [logMAR] |
0.105
(0.0119)
|
0.529
(0.0127)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TFNT00, SN60AT |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye |
|---|---|
| Description | The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure. |
| Time Frame | Up to Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 129 | 114 |
| Measure Eyes | 129 | 114 |
| Count of Units [Eyes] |
1
|
0
|
| Title | Mean Photopic Without Glare Binocular Distance Contrast Sensitivity |
|---|---|
| Description | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set with contrast sensitivity test |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| 3 cpd |
1.752
(0.2080)
|
1.733
(0.1989)
|
| 6 cpd |
1.923
(0.2349)
|
1.940
(0.2328)
|
| 12 cpd |
1.527
(0.2793)
|
1.558
(0.2566)
|
| 18 cpd |
0.993
(0.2874)
|
1.090
(0.2661)
|
| Title | Mean Photopic With Glare Binocular Distance Contrast Sensitivity |
|---|---|
| Description | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set with contrast sensitivity test |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| 3 cpd |
1.759
(0.1890)
|
1.753
(0.1928)
|
| 6 cpd |
1.897
(0.2322)
|
1.971
(0.1952)
|
| 12 cpd |
1.566
(0.2728)
|
1.593
(0.2659)
|
| 18 cpd |
1.037
(0.2762)
|
1.121
(0.2537)
|
| Title | Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity |
|---|---|
| Description | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set with contrast sensitivity test |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| 1.5 cpd |
1.673
(0.2601)
|
1.679
(0.2190)
|
| 3 cpd |
1.717
(0.2397)
|
1.689
(0.2177)
|
| 6 cpd |
1.715
(0.2875)
|
1.777
(0.2871)
|
| 12 cpd |
1.211
(0.4047)
|
1.290
(0.4384)
|
| Title | Mean Mesopic With Glare Binocular Distance Contrast Sensitivity |
|---|---|
| Description | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set with contrast sensitivity test |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| 1.5 cpd |
1.658
(0.2296)
|
1.678
(0.2091)
|
| 3 cpd |
1.709
(0.2307)
|
1.692
(0.2089)
|
| 6 cpd |
1.691
(0.3238)
|
1.786
(0.2775)
|
| 12 cpd |
1.129
(0.4146)
|
1.233
(0.4599)
|
| Title | Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) |
|---|---|
| Description | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set with data at visit |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 113 |
| Measure Eyes | 127 | 113 |
| Least Squares Mean (Standard Error) [logMAR] |
0.070
(0.0108)
|
0.327
(0.0114)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TFNT00, SN60AT |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.257 | |
| Confidence Interval |
(2-Sided) 95% -0.287 to -0.227 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0153 |
|
| Estimation Comments | ||
| Title | Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire |
|---|---|
| Description | The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with bilateral implantation and concordant, non-missing data. |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 123 | 110 |
| Number [percentage of subjects] |
80.5
|
8.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TFNT00, SN60AT |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mantel-Haenszel common difference |
| Estimated Value | 71.2 | |
| Confidence Interval |
(2-Sided) 95% 61.87 to 80.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) |
|---|---|
| Description | QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with bilateral implantation and non-missing data. |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| Starbursts |
20
15.5%
|
2
1.8%
|
| Halos |
16
12.4%
|
1
0.9%
|
| Glare |
4
3.1%
|
2
1.8%
|
| Hazy vision |
0
0%
|
0
0%
|
| Blurred vision |
0
0%
|
0
0%
|
| Double vision |
0
0%
|
0
0%
|
| Dark area |
0
0%
|
0
0%
|
| Title | Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID |
|---|---|
| Description | Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. |
| Time Frame | Month 6 (Day 120-180), post second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects with bilateral implantation and non-missing data. |
| Arm/Group Title | TFNT00 | SN60AT |
|---|---|---|
| Arm/Group Description | AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. | AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal. |
| Measure Participants | 127 | 111 |
| Starbursts |
6
4.7%
|
1
0.9%
|
| Halos |
3
2.3%
|
1
0.9%
|
| Glare |
2
1.6%
|
1
0.9%
|
| Hazy vision |
0
0%
|
1
0.9%
|
| Blurred vision |
0
0%
|
2
1.8%
|
| Double vision |
0
0%
|
0
0%
|
| Dark area |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Implantation through study completion, an average of 7 months | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes." | |||||||||||||
| Arm/Group Title | Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic | |||||||
| Arm/Group Description | All subjects in the safety analysis set prior to initiation of treatment. | All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. | All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. | All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00. | All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT. | All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT. | All subjects implanted with AcrySof Monofocal IOL Model SN60AT. | |||||||
All Cause Mortality |
||||||||||||||
| Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/243 (0%) | 2/129 (1.6%) | 2/127 (1.6%) | 4/129 (3.1%) | 2/114 (1.8%) | 1/111 (0.9%) | 3/114 (2.6%) | |||||||
| Cardiac disorders | ||||||||||||||
| Acute myocardial infarction | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Age-related macular degeneration | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 1/114 (0.9%) | 1/111 (0.9%) | 0/114 (0%) | |||||||
| Cystoid macular oedema | 0/243 (0%) | 0/129 (0%) | 1/127 (0.8%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Posterior capsule rupture | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 1/114 (0.9%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Vitreous prolapse | 0/243 (0%) | 0/129 (0%) | 1/127 (0.8%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Retinal tear | 0/243 (0%) | 1/129 (0.8%) | 0/127 (0%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal wall haematoma | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Ileus | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholecystitis acute | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 1/114 (0.9%) | |||||||
| Cholelithiasis | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 1/114 (0.9%) | |||||||
| Infections and infestations | ||||||||||||||
| Diverticulitis | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Breast neoplasm | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 1/114 (0.9%) | |||||||
| Product Issues | ||||||||||||||
| Device dislocation | 0/243 (0%) | 0/129 (0%) | 1/127 (0.8%) | 0/129 (0%) | 1/114 (0.9%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Acute kidney injury | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 1/114 (0.9%) | |||||||
| Surgical and medical procedures | ||||||||||||||
| Colectomy | 0/243 (0%) | 0/129 (0%) | 0/127 (0%) | 1/129 (0.8%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Intra-ocular injection | 0/243 (0%) | 1/129 (0.8%) | 2/127 (1.6%) | 1/129 (0.8%) | 1/114 (0.9%) | 1/111 (0.9%) | 0/114 (0%) | |||||||
| Intraocular lens repositioning | 0/243 (0%) | 0/129 (0%) | 1/127 (0.8%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Lens extraction | 0/243 (0%) | 1/129 (0.8%) | 0/127 (0%) | 0/129 (0%) | 1/114 (0.9%) | 0/111 (0%) | 0/114 (0%) | |||||||
| Vitrectomy | 0/243 (0%) | 0/129 (0%) | 1/127 (0.8%) | 0/129 (0%) | 0/114 (0%) | 0/111 (0%) | 0/114 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Preoperative | TFNT00 - 1st Eye | TFNT00 - 2nd Eye | TFNT00 - Systemic | SN60AT - 1st Eye | SN60AT - 2nd Eye | SN60AT - Systemic | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/243 (0.4%) | 24/129 (18.6%) | 24/127 (18.9%) | 0/129 (0%) | 10/114 (8.8%) | 7/111 (6.3%) | 0/114 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Posterior capsule opacification | 0/243 (0%) | 17/129 (13.2%) | 19/127 (15%) | 0/129 (0%) | 4/114 (3.5%) | 5/111 (4.5%) | 0/114 (0%) | |||||||
| Investigations | ||||||||||||||
| Intraocular pressure increased | 1/243 (0.4%) | 7/129 (5.4%) | 5/127 (3.9%) | 0/129 (0%) | 6/114 (5.3%) | 2/111 (1.8%) | 0/114 (0%) | |||||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Expert Clinical Project Lead, CDMA Surgical |
|---|---|
| Organization | Alcon Research |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- ILH297-C001